/ CompletedNot Applicable 吸入用布地奈德混悬液在中国健康受试者中的人体生物等效性研究
[Translation] Human bioequivalence study of budesonide suspension for inhalation in Chinese healthy subjects
主要研究目的：以Astrazeneca Pty Ltd持证的吸入用布地奈德混悬液（普米克令舒）为参比制剂，以南京力成药业有限公司研发的吸入用布地奈德混悬液为受试制剂，通过单中心、随机、开放、两序列、四周期完全重复交叉临床研究来评价两种制剂在空腹条件下的人体生物等效性。
次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to use the budesonide suspension for inhalation (Pulmicort Respules) licensed by Astrazeneca Pty Ltd as the reference preparation and the budesonide suspension for inhalation developed by Nanjing Licheng Pharmaceutical Co., Ltd. as the test preparation, and to evaluate the bioequivalence of the two preparations under fasting conditions through a single-center, randomized, open, two-sequence, four-cycle complete repeated crossover clinical study.
Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.
/ CompletedNot Applicable 吸入用布地奈德混悬液在中国健康受试者中的人体生物等效性研究
[Translation] Human bioequivalence study of budesonide suspension for inhalation in Chinese healthy subjects
主要研究目的：以Astrazeneca Pty Ltd持证的吸入用布地奈德混悬液（普米克令舒）为参比制剂，以南京力成药业有限公司研发的吸入用布地奈德混悬液为受试制剂，通过单中心、随机、开放、两序列、四周期完全重复交叉临床研究来评价两种制剂在空腹状态下的人体生物等效性。
次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to use the budesonide suspension for inhalation (Pulmicort Respules) licensed by Astrazeneca Pty Ltd as the reference preparation and the budesonide suspension for inhalation developed by Nanjing Licheng Pharmaceutical Co., Ltd. as the test preparation to evaluate the bioequivalence of the two preparations in the fasting state through a single-center, randomized, open, two-sequence, four-cycle complete repeated crossover clinical study.
Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.
/ CompletedNot Applicable 吸入用布地奈德混悬液在活性炭阻断条件下的人体生物等效性研究
[Translation] Study on the bioequivalence of budesonide suspension for inhalation in healthy volunteers under activated carbon blocking conditions
主要研究目的：以Astrazeneca Pty Ltd持证的吸入用布地奈德混悬液（普米克令舒）为参比制剂，以南京力成药业有限公司研发的吸入用布地奈德混悬液为受试制剂，通过单中心、随机、开放、两序列、四周期完全重复交叉临床研究来评价两种制剂在空腹有活性炭阻断条件下的人体生物等效性。
次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to use the budesonide suspension for inhalation (Pulmicort Respules) licensed by Astrazeneca Pty Ltd as the reference preparation and the budesonide suspension for inhalation developed by Nanjing Licheng Pharmaceutical Co., Ltd. as the test preparation, and to evaluate the bioequivalence of the two preparations in humans under fasting conditions with activated carbon blocking through a single-center, randomized, open, two-sequence, four-cycle completely repeated crossover clinical study.
Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.
100 Clinical Results associated with Nanjing Licheng Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Nanjing Licheng Pharmaceutical Co., Ltd.
100 Deals associated with Nanjing Licheng Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Nanjing Licheng Pharmaceutical Co., Ltd.
